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NIH: H7N9 Avian Flu Vaccine Now Being Tested

Two concurrent Phase 2 clinical trials, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), will evaluate the safety of Sanofi Pasteur's investigational H7N9 avian influenza vaccine and the immune system responses it induces when administered at different dosages, with or without adjuvants in adults ages 19–64.

The vaccine was developed from inactivated H7N9 virus isolated in Shanghai, China. The use of adjuvants are being tested with this vaccine because previous research regarding H7 influenza viruses has suggested that two vaccine doses without adjuvant may not produce an adequate immune response.

As of August 12, 2013, a total of 135 confirmed human cases of H7N9 influenza, including 44 deaths, have been reported by the World Health Organization. No H7N9 influenza cases have been reported outside of China and the virus has not been shown through human-to-human transmission.

However, there is growing concern that the H7N9 influenza virus can mutate and become a greater public health threat.

The first trial will enroll as many as 700 patients who will be randomized to 1 of 7 groups. Each group will receive two equal vaccine doses (3.75mcg, 75.mcg, 15mcg or 45mcg) approximately 21 days apart. Five groups will receive vaccinations along with Novartis' MF59 adjuvant. This adjuvant is also contained in the Fluad seasonal influenza vaccine licensed in Europe and Canada.

The second trial will enroll as many as 1,000 patients who will be randomized to 1 of 10 groups. Each group will receive two equal vaccine doses (same as the first trial) approximately 21 days apart. Seven groups will receive vaccinations with or without GlaxoSmithKline's AS03 adjuvant. This adjuvant is contained in Pandemrix vaccine, which was used in several European countries during the 2009–2010 H1N1 influenza pandemic.

The safety data of both studies will be monitored by an independent panel of experts and are expected to conclude in December 2014.